The Safety and Tolerability of 5-Aminolevulinic Acid Phosphate with Sodium Ferrous Citrate in Patients with Type 2 Diabetes Mellitus in Bahrain

Table 3

Cumulative summary of treatment emergent adverse events over time.

	Week 2 (100 mg 5-ALA-SFC); ()	Week 4 (150 mg 5-ALA-SFC); ()	Week 6 (200 mg 5-ALA-SFC); ()	Week 12 (200 mg 5-ALA-SFC); ()	Week 12 (Placebo); ()
Subjects reporting at least one event	6 (17.1%)	14 (40.0%)	15 (42.9%)	16 (45.7%)	5 (27.8%)
Abdominal distension	0	1 (2.9%)	1 (2.9%)	1 (2.9%)	0
Abdominal pain upper	1 (2.9%)	2 (5.7%)	2 (5.7%)	2 (5.7%)	0
Alopecia	0	1 (2.9%)	1 (2.9%)	1 (2.9%)	0
Blood glucose increased	0	0	1 (2.9%)	1 (2.9%)	0
Constipation	0	1 (2.9%)	1 (2.9%)	1 (2.9%)	0
Cough	1 (2.9%)	2 (5.7%)	2 (5.7%)	2 (5.7%)	0
Decreased appetite	0	1 (2.9%)	1 (2.9%)	1 (2.9%)	0
Diarrhea	2 (5.7%)	2 (5.7%)	2 (5.7%)	2 (5.7%)	2 (11.1%)
Dyspepsia	1 (2.9%)	1 (2.9%)	1 (2.9%)	1 (2.9%)	1 (5.6%)
Erectile dysfunction	0	0	1 (2.9%)	1 (2.9%)	0
Fatigue	0	1 (2.9%)	2 (5.7%)	2 (5.7%)	0
Feces discolored	0	1 (2.9%)	1 (2.9%)	1 (2.9%)	0
Feces hard	0	1 (2.9%)	1 (2.9%)	1 (2.9%)	0
Gastrointestinal disorder	0	0	1 (2.9%)	1 (2.9%)	0
Groin pain	0	0	0	0	1 (5.6%)
Headache	0	1 (2.9%)	1 (2.9%)	2 (5.7%)	1 (5.6%)
Hypoglycemia	0	0	0	1 (2.9%)	1 (5.6%)
Hypokalemia	0	0	0	0	1 (5.6%)
Nasal abscess	0	0	0	1 (2.9%)	0
Nasal congestion	1 (2.9%)	1 (2.9%)	1 (2.9%)	1 (2.9%)	0
Nausea	0	1 (2.9%)	1 (2.9%)	1 (2.9%)	0
Palpitations	0	0	1 (2.95)	1 (2.9%)	0
Pyrexia	0	1 (2.9%)	1 (2.9%)	1 (2.9%)	0